BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073168 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02525
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND THAT THE HELIX WAS CLOGGED WITH DRIED BODY FLUID, PREVENTING IT FROM EXTENDING. THIS RESULTED IN AN OVERTORQUE CONDITION. THE DAMAGE IS CONSISTENT WITH THAT OCCURRING DURING THE SURGICAL PROCEDURE. NO DEFECTS IN MATERIALS OR WORKMANSHIP WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED. THE PATIENT HAD A TIGHT CLAVICLE AREA WHICH DAMAGED THE SVC COIL. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention